1. Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions.
- Author
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Taylor MA, Godwin AC, Hoque S, and Bennett CL
- Subjects
- United States, Humans, Clopidogrel, Thalidomide, Ticlopidine, Immunotherapy, Drug-Related Side Effects and Adverse Reactions
- Abstract
About 1-10% of all serious adverse drug reactions (sADRs) are reported to the Food and Drug Administration (FDA) ( Moore T, Bennett C. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR). Semin Thromb Hemost. 2012;38(08):905-907. https://doi.org/10.1055/s-0032-1328890 ). Prevailing opinion suggests that low reporting rates reflect time constraints., (© 2022. The Author(s), under exclusive license to Springer Nature Switzerland AG.)
- Published
- 2022
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